Status:
ACTIVE_NOT_RECRUITING
Effects of a Multi-strain Oral Probiotic on the Vaginal Microbiota Composition in Healthy Women and Women with Endometriosis
Lead Sponsor:
University of Roma La Sapienza
Conditions:
Endometriosis
Bacterial Vaginosis
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
Endometriosis is a chronic inflammatory disease affecting approximately 10-15% of reproductive age women, and, in recent years, an association between this pathology and dysbiosis, either involving th...
Eligibility Criteria
Inclusion
- age between 20 and 40 years old;
- clinical diagnosis of endometriosis via gynecological examination and transvaginal ultrasound (TVUS);
- genital healthy condition as confirmed via gynecological examination.
Exclusion
- pre-menarche or menopause status;
- diabetes, neoplastic diseases, urinary or genital infections in the past 6 months
- bowel and/or liver disorders;
- current treatment with oral contraceptive or progestins, prokinetics, antacids or proton pump in-hibitors;
- sexual activity in the week before sampling;
- recent or current antibiotic treatment (oral or topical);
- the use of probiotics and/or prebiotics for three months before the enrolment.
Key Trial Info
Start Date :
October 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2025
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT06592976
Start Date
October 21 2020
End Date
May 31 2025
Last Update
September 19 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Umberto I Hospital, University of Rome "Sapienza"
Rome, Lazio, Italy, 00185